Security

Built for careful research operations.

TrialBridge keeps review status, protocol evidence, permissions, and audit history visible across enrollment workflows.

TrialBridge does not make final eligibility determinations. Scope below reflects covered clinical operations only.

Permission matrix

Role	Candidates	Eligibility	Messages	Reports
Coordinator	Edit	Edit	Approve	Edit
Sub-I / PI	Edit	Edit	Approve	Edit
Sponsor	Read	—	—	Summary
Auditor	Read	Read	Read	Read

Audit log

14:31M. ReyesEligibility locked · CAND-0421
14:08M. ReyesReminder approved · CAND-0407
13:42Dr. ParkProtocol query · §5.2.4
13:11M. ReyesExport · weekly · PDF

Reminder template

Approved

Hi — this is a reminder of your study visit on {date}. Reply YES to confirm or call the site to reschedule.

v4 · approved by M. Reyes

Protocol citation

§5.2.4 · v3.1

“No anti-HER2 therapy within 21 days prior to first study drug.”
ONC-204 · §5.2.4 · v3.1 · p. 27

Export privacy · summary levelSponsor view

Security posture

Scoped, stated plainly.

TrialBridge is workflow support for clinical research operations, not medical advice, not IRB review, and not a substitute for investigator or coordinator confirmation.

TLS 1.3 in transit and AES-256 at rest.
Role-based access control enforced at the API gateway level.
Clinical data logs retained for 7 years.
Manual override paths are logged in immutable audit trails.

Scope is limited to the workflows described above. TrialBridge does not make final eligibility determinations. These statements are not a guarantee of outcome, an uptime commitment, or BAA coverage beyond covered clinical operations.

Authority boundary

AI prepares the enrollment path. Site teams make the decision.

What TrialBridge may do automatically

Data mapping
Eligibility scoring
Report generation
Draft sponsor notifications
Priority visit reminders where customer-approved portal workflows are configured

What requires human review

Critical Risk red/orange flags
Final eligibility decisions
Investigator/coordinator confirmation
Sponsor-facing exports where the site requires approval

Critical Risk red/orange flags require human sign-off before action. Manual overrides are recorded in immutable audit trails.

Role-based access

One workspace, one permission model.

Each role sees what it needs to do its job — and nothing more. Permissions are enforced everywhere, including exports and integrations.

Site Admin

Manages users, roles, integrations, and template approvals.

UsersTemplatesIntegrations

Principal Investigator

Reviews escalations, signs off on eligibility, and oversees protocol compliance.

Eligibility sign-offProtocolEscalations

Clinical Research Coordinator

Runs the daily brief, eligibility, visits, and reminders.

BriefEligibilityVisits

Recruitment Coordinator

Works the candidate pipeline, imports, and outreach drafts.

PipelineImportsDrafts

Sponsor / CRO Viewer

Reads approved summary-level views, scoped to assigned studies.

Summary viewScoped

Read-only Auditor

Reads everything in scope. Cannot write or send.

Read-onlyAudit

Human review by design

Decision support prepares. Site teams decide.

No autonomous actions. The system surfaces suggestions with confidence; coordinators and investigators decide. Every decision is recorded with the actor and timestamp.

Eligibility — CAND-0421

Coordinator review required

Match confidence

0.86

Suggested · not decided

Coordinator

M. Reyes

Review required to lock

PI escalation

Dr. Park

Notified on lock

Decision history

Apr 06 · 11:45M. ReyesEligibility locked · 6/6 met
Apr 04 · 14:31M. ReyesECOG requested · §5.2.4
Apr 03 · 09:02System5/6 criteria met · ECOG missing

Protocol evidence

Every answer cites its source.

Eligibility checks and copilot answers reference section, protocol version, and page. Where evidence is missing, the answer is withheld.

Cited answer

§5.2.4 · v3.1

Minimum 21 days from last anti-HER2 administration before the screening visit.

“No anti-HER2 therapy within 21 days prior to first study drug.”
ONC-204 · §5.2.4 · v3.1 · p. 27

Missing-citation safe state

When the protocol does not contain a clear source, the answer is withheld and routed for coordinator review instead of being shown.

“No supported citation found in ONC-204 v3.1.”

Sent to coordinator

Approval-controlled messaging

Only approved templates can be sent.

Every message goes through Draft → Needs Review → Approved before it can leave the workspace. Archived templates can’t be re-used by accident.

Reminder & outreach templates

Draft

Coordinator authoring.

Needs Review

Awaiting approver.

Approved

Eligible to send.

Archived

No longer in use.

Visit reminder · v4Approved

Hi — this is a reminder of your study visit on {date}. Reply YES to confirm or call the site to reschedule.

Approved by M. Reyes · 2024-04-02 11:08 Only approved templates can send

Audit history

Every action recorded, in order.

An append-only log of who did what, when, on which entity, and against which study — including every export.

Audit history

Append-only

Timestamp	Actor	Action	Entity	Study
2024-04-09 14:31	M. Reyes	Eligibility locked	CAND-0421	ONC-204
2024-04-09 14:08	M. Reyes	Reminder approved	Template v4	ONC-204
2024-04-09 13:42	Dr. Park	Protocol query	§5.2.4	ONC-204
2024-04-09 13:11	M. Reyes	Export · weekly PDF	Report-W14	ONC-204
2024-04-09 11:02	System	Match scored	CAND-0431	ONC-204

Includes export trailOpen full log

Privacy-aware reports

Share progress, not raw records.

Reports respect each role’s access. Sponsor and CRO viewers see approved summary-level views; identifiers and free-text fields stay inside the site.

Sponsor summary — week 14

CSVPDFApproved

Pre-screened

Eligible

Enrolled

Field-level visibility

Candidate identifiersHidden
Aggregate countsShown
Site-level breakdownShown
Free-text notesHidden

Sponsor / CRO viewers see approved summary-level views according to permissions.

Keep every enrollment action traceable.

See how TrialBridge handles roles, reviews, and audit history on a study you’re recruiting for.

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